Pressure and Temperature Sensor for Therapeutic Compression Garments

Completed

• Conditions: Healthy Adults; Venous Leg Ulcer
• Interventions: Device: Pressure and Temperature Sensor

• Registration Number: NCT03461549
• Lead Sponsor: Northwestern University

Brief Summary

Pilot study of a soft, flexible pressure and temperature sensor

Detailed Description

Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.

Study Timeline

• Study Start: 2018-02-27
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Primary Completion: 2020-07-08
• Study Completion: 2021-08-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Healthy adults over the age of 18 years old

Read More

Exclusion Criteria

• Subjects with history of medical or surgical problems

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Venous Leg Ulcer Adults	Pressure and Temperature Sensor	Evaluate sensor performance on both lower limbs of adult subjects with an active venous leg ulcer or history of a venous leg ulcer for pressure sensing and skin temperature sensing.
Healthy adults	Pressure and Temperature Sensor	Evaluate sensor performance on both lower limbs of healthy adult subjects for pressure sensing and skin temperature sensing.

Primary Outcome Measures

Name	Time	Method
Pressure comparison with PicoPress	72 hours	Percent variation for each subject for pressure
Temperature with a comparator device (infrared camera)	72 hours	Percent variation for each subject for temperature

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale of skin irritation	72 hours	A minimum score is 0 and a maximum score is 100 with a range of 0-100. A score of 0 is defined as no visible clinical appreciation. A score of 100 is defined as severe skin irritation. Higher values indicate worse outcome. There are no subscales.
Participant survey	15 minutes	Survey regarding the comfort of the sensor

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States